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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS STEREOTACTIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. HANDPIECE MICS STEREOTACTIC DEVICE, ROBOTICS Back to Search Results
Catalog Number 209063
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2016
Event Type  Malfunction  
Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.

 
Event Description

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed). After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code. After opening the tha software a burr status mismatch call service error code occurred. The surgeon completed the case manually.

 
Manufacturer Narrative

Reported event: it was reported that a handpiece was not functioning. Issue was noticed prior to a case, there was a case delay and the case was completed manual. Device history review: review of the device history records indicate (b)(4) devices were manufactured under lot k0672 and (b)(4) including 4000316 were accepted into final stock on 11/12/2015. " visual inspection: visual inspection revealed no physical damage of unit. Dimensional inspection: dimensional inspection was not completed. Reported problem was a functional issue. Functional inspection: the handpiece was tested in the handpiece test (qip0243) and passed. The motor spun as expected during the test. The cable was agitated during the test and the unit remained functional. Screenshot of passing test is attached. A review of complaints related to p/n 209063 shows the failure to operate in 19 other complaints was unable to be duplicated. These complaint investigations are: (b)(4). Issues for p/n 209063 will be completed through trend request #900. Conclusions: failure was not duplicated. The handpiece was tested in the handpiece test (qip0243) and passed. The motor spun as expected during the test. The cable was agitated during the test and the unit remained functional. Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard. ".

 
Event Description

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed). After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code. After opening the tha software a burr status mismatch call service error code occurred. The surgeon completed the case manually.

 
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Brand NameHANDPIECE MICS
Type of DeviceSTEREOTACTIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
michael mcavenia
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key6145946
MDR Text Key61465276
Report Number3005985723-2016-00412
Device Sequence Number1
Product Code OLO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK141989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number209063
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/05/2016 Patient Sequence Number: 1
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